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Trial to evaluate the effect of low-dose hormone therapy on menopausal symptoms and markers of bone turnover in postmenopausal women

Condition category

Urological and Genital Diseases

Date applied

06/12/2011

Date assigned

11/01/2012

Last edited

14/07/2015

Prospective/Retrospective

Prospectively registered

Overall trial status

Completed

Recruitment status

No longer recruiting

Plain English Summary

Background and study aimsIn recent decades, hormonal therapy has been used to treat postmenopausal women to control the effects of estrogen deprivation (lack of estrogen) and improve quality of life. Currently, the global trend is to reduce the doses of hormones in order to reduce the side effects. Therefore, the aim of this study is to evaluate the clinical effectiveness and safety of ultra low dose hormone therapy in postmenopausal women, assessing the improvement of menopausal symptoms (vasomotor symptoms [night sweats, hot flashes, and flushes], bleeding and vaginal maturation), bone remodeling and quality of life.

Who can participate?120 female patients (60 per treatment group) in post natural menopause having at least seven hot flashes per day or 50 hot flashes within one week will be enrolled in this study.

What does the study involve?Patients will be randomly allocated to receive either the study drug or a placebo (dummy) drug for 24 weeks. Regardless of the treatment group, patients will also receive calcium and vitamin D supplementation.

What are the possible benefits and risks of participating?In previous studies, the following adverse reactions were observed in less than 5% of women who used the study drug: body ache, headache, pain in extremity, nausea, diarrhea, nasopharyngitis, endometrial thickening and vaginal bleeding. The following adverse reactions were observed in less than 5% of women taking a placebo: headache, diarrhea, nasopharyngitis, and vaginal bleeding.Regarding benefits, the study medication may help treat symptoms of menopause.

Where is the study run from?This study will run only in Brazil and around 120 patients will be recruited in eight study centers. The coordinator center is Vox Femina, located in Jundiai city, state of Sao Paulo.

When is the study starting and how long is it expected to run for?The first visit of the first patient is planned to start in May 2012 and the study will enrol patients until August 2012. As the maximum study period for each participant is 28 weeks, the last visit of the last patient is expected in March 2013.

Who is funding the study?This study is sponsored by Libbs Pharmaceutical Ltda (Brazil).